Penile Neoplasms
Conditions
Interventions
This is a randomized, controlled, two-arm, double-blind clinical study. Experimental group: 45 men with penile cancer without clinical suspicion of lymph node involvement (cN0), but with intermediate-
E04.446
Sponsors
Instituto do Câncer do Ceará
Instituto do Câncer do Ceará
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men with Squamous Cell Carcinoma - SCC of the penis; minimum age 18 years; patients without clinical suspicion of lymph node involvement , but with an intermediate-risk penile tumoror high-risk ; patients with clinical suspicion of lymph node involvement, but with lymph nodes up to 3 cm and not fixed to the skin or deeper structures and without distant metastases
Exclusion criteria
Exclusion criteria: Patients without clinical suspicion of lymph node involvement and with low-risk penile tumor ; patients with clinical suspicion of lymph node involvement, but with lymph nodes larger than 3 cm and/or fixed to the skin or deeper structures and/or distant metastases; patients undergoing neoadjuvant radiotherapy or chemotherapy; dementia, psychiatric or cognitive status that prevents full understanding of the explanations and implications of the research project and treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness and cost-effectiveness of the Robot-Assisted Laparoscopic Inguinal Lymphadenectomy technique in relation to Open Inguinal Lymphadenectomy in the treatment of patients with Squamous cell carcinoma of the penis in the Unified Health System of the State of Ceará. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the rate of complications (skin necrosis, wound dehiscence, infection, lymphocele, lymphorrhea, vascular injury, neurological injury, deep vein thrombosis, lymphedema and bleeding) in patients undergoing Robotic-Assisted Laparoscopic Inguinal Lymphadenectomy in patients with SCC of the penis compared to Open Inguinal Lymphadenectomy. To evaluate the oncological non-inferiority, in relation to the number of lymph nodes removed, of Robotic-Assisted Laparoscopic Inguinal Lymphadenectomy in patients with SCC of the penis compared to Open Inguinal Lymphadenectomy. To evaluate the cost-effectiveness and quality do life of Robotic-Assisted Laparoscopic Inguinal Lymphadenectomy in patients with Squamous cell carcinoma of the penis compared to Open Inguinal Lymphadenectomy in the Unified Health System (SUS). | — |
Countries
Brazil
Contacts
Public ContactEmanuel de Albuquerque
Instituto do Câncer do Ceará
Outcome results
None listed